Stent delivery system having stent securement apparatus

ABSTRACT

A system/assembly for delivery and deployment of an inflation expandable stent within a vessel, comprising a catheter having proximal and distal ends; a stent, inflation expandable from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter for conforming the stent to the catheter, such that the stent, in its delivery diameter, is coaxially mounted on the catheter near the catheter distal end; an expandable inflation means coaxially mounted on the catheter axially within the stent, for expansion of the stent from the delivery diameter to the deployment diameter upon application of fluid deployment pressure to the inflation means; and a securement component coaxially mounted on the catheter, axially within the expandable inflation means, the securement component designed and adapted to provide a securement pressure to the stent in the delivery diameter to maintain the stent in position on the catheter during delivery to the deployment site.

[0001] The present application is a Continuation-in-part applicationbased on U.S. Ser. No. 08/807,791 filed Feb. 28, 1997, U.S. Ser. No.08/702,150 filed Aug. 23, 1996, U.S. Ser. No. 08/697,453 filed Aug. 23,1996, and U.S. Ser. No. 08/701,979, filed Aug. 23, 1997, all of whichare incorporated by reference in their entirety.

FIELD OF THE INVENTION

[0002] This invention relates to an assembly and method for deliveringand deploying an inflation expandable stent, particularly within a lumenof a body vessel. More specifically, this invention relates to stentsecurement devices most notably positioned between the balloon and theinner shaft of the catheter.

BACKGROUND OF THE INVENTION

[0003] Stents and stent delivery assemblies are utilized in a number ofmedical procedures and situations, and as such their structure andfunction are well-known. A stent is a general cylindrical prosthesisintroduced via a catheter into a lumen of a body vessel in aconfiguration having a generally reduced diameter and then expanded tothe diameter of the vessel. In its expanded configuration, the stentsupports and reinforces the vessel walls while maintaining the vessel inan open, unobstructed condition.

[0004] Both self-expanding and inflation expandable stents arewell-known and widely available. Self-expanding stents must bemaintained under positive external pressure in order to maintain theirreduced diameter configuration during delivery of the stent to itsdeployment site. Inflation expandable stents (also known as balloonexpandable stents) are crimped to their reduced diameter about thedelivery catheter, positioned at the deployment site, and then expandedto the vessel by diameter by fluid inflation of the balloon positionedbetween the stent and the delivery catheter. The present invention isparticularly concerned with enhanced stent securement and safer stentloading in the delivery and deployment of balloon expandable stents.

[0005] In angioplasty procedure, there may be restenosis of the artery,which either necessitates another angioplasty procedure, a surgicalbi-pass procedure, or some method of repairing or strengthening thearea. To prevent restenosis and strengthen the area, a physician canimplant an intravascular prosthesis for maintaining vascular patency,i.e. a stent, inside the artery at the lesion. The stent is expanded toa larger diameter for placement in the vasculature, often by the balloonportion of the catheter. Stents delivered to a restricted coronaryartery, expanded to a larger diameter as by a balloon catheter, and leftin place in the artery at the site of a dilated lesion are shown in U.S.Pat. No. 4,740,207 to Kreamer; U.S. Pat. No. 5,007,926 to Derbyshire;U.S. Pat. No. 4,733,665 to Palmaz; U.S. Pat. No. 5,026,377 to Burton etal.; U.S. Pat. No. 5,158,548 to Lau et al.; U.S. Pat. No. 5,242,399 toLau et al.; U.S. Pat. No. 5,344,426 to Lau et al.; U.S. Pat. No.5,415,664 to Pinchuck; U.S. Pat. No. 5,453,090 to Martinez et al.; U.S.Pat. No. 4,950,227 to Savin; U.S. Pat. No. 5,403,341 to Solar; U.S. Pat.No. 5,108,416 to Ryan et al.; and European Patent Application No.707837A1 to Scheiban, all of which are incorporated herein by reference.A stent particularly preferred for use with this invention is describedin PCT Application No. 96/03092-A1, published 8 Feb. 1996, the contentof which is incorporated herein by reference.

[0006] In advancing a balloon expandable stent through a body vessel tothe deployment site, there are a number of important considerations. Thestent must be able to securely maintain its axial position on thedelivery catheter. The stent, particularly its distal and proximal ends,are sometimes protected to prevent distortion of the stent, and minimizetrauma to the vessel walls. Balloon expandable stent delivery anddeployment assemblies are known which utilize restraining means thatoverlay the stent during delivery. U.S. Pat. No. 4,950,227 to Savin etal., relates to a balloon expandable stent delivery system in which asleeve overlaps the distal or proximal margin (or both) of the stentduring delivery. During inflation of the stent at the deployment site,the stent margins are freed of the protective sleeve(s) and the sleevesthen collapse toward the delivery catheter for removal. A number ofballoon expandable stent delivery and deployment assemblies do not useoverlaying restraining members, such as the Savin sleeves, to positionthe stent for delivery. European Patent Application No. EP 055 3960A1 toLau et al., uses an elastic sheath interspaced between the balloon andthe stent. The sheath is said to act as a barrier to protect the balloonfrom the stent, allow uniform stent expansion, decrease balloondeflation time, prevent undesirable balloon flattening upon deflationand provide a friction substrate for the stent. The Lau sheath can bepositioned on the inside or outside of the balloon. U.S. Pat. No.5,409,495 to Osborne, similarly uses an elastic sleeve or sheathsurrounding and in contact with the balloon for controlling the balloonradial expansion. In addition, Osborne is said to use restraining bandsor a pair of balloons to achieve controllable stent expansioncharacteristics. U.S. Pat. No. 5,403,341 to Solar, relates to stentdelivery and deployment assembly which uses a retaining sheathpositioned about opposite ends of the compressed state. The retainingsheaths of Solar are adapted to tear under pressure as the stent isradially expanded, thus releasing the stent for engagement with thesheaths. U.S. Pat. No. 5,108,416 to Ryan et al. describes a stentintroducer system which uses one or two flexible end caps and annularsocket surrounding the balloon to position the stent during introductionto the deployment site. The content of all of these patents isincorporated herein by reference.

[0007] In positioning a balloon expandable stent on the deliverycatheter over the fluid expandable balloon, the stent must be smoothlyand evenly crimped to closely conform to the overall profile of thecatheter and the unexpanded balloon. It has been noted that, due tophysical properties of the material used in manufacturing the stent(typically a shaped memory metal, such as stainless steel or Nitinol™)there is a certain amount of “recoil” of the stent despite the mostcareful and firm crimping. That is the stent evidences a tendency toslightly open up from the fully crimped position and once the crimpingforce has been released. For example, in the typical stent delivery anddeployment assembly, if the stent has been fully crimped to a diameterof approximately 0.0035″, the stent has been observed to open up orrecoil to approximately 0.0037″. This phenomenon has been characterizedas “recoil crimping”. Due to recoil crimping to this slightly enlargeddiameter, it can be understood that the stent tends to evidence acertain amount of looseness from its desired close adherence to theoverall profile of the underlying catheter and balloon. That is, thestent tends to have a perceptible relatively slack fit in its mountedand crimped position. During delivery, the stent can thus tend to slipand dislocate from its desired position on the catheter or even becomeseparate from the catheter, requiring further intervention by thephysician.

[0008] According to the present invention, a securement device issecured over the inner catheter beneath the balloon to compensate forthe undesired looseness or slack that due to recoil crimping and to aidin securing the stent to the balloon, as well as protecting the balloonmaterial from being sandwiched between the stent and any metal orprotruding item which may be mounted on the inner shaft/guide wirelumen, for delivery of the stent. The securement devices secure thestent during tracking and delivery and provide a good friction fit tothe stent and insure good contact between the stent and underlyingballoon and catheter, instead of merely crimping the stent onto theballoon and the underlying catheter and relying on the bulk of theflaccid balloon to hold the stent on.

[0009] The art referred to and/or described above is not intended toconstitute an admission that any patent, publication or otherinformation referred to herein is “prior art” with respect to thisinvention. In addition, this section should not be construed to meanthat a search has been made or that no other pertinent information asdefined in 37 C.F.R. §1.56(a) exists.

SUMMARY OF THE INVENTION

[0010] This invention concerns a catheter apparatus suitable forperforming angioplasty and for delivery of stents to body cavities. Ingeneral, stents are prosthetic devices which can be positioned within abody cavity, for example, a blood vessel or in some other difficultlyaccessible place of the body of a living human or animal. The stentprosthesis is formed of a generally tubular body, the diameter of whichcan be decreased or increased. Stents are particularly useful forpermanently widening a vessel which is either in a narrowed state, orinternally supporting a vessel damaged by an aneurysm. Such stents aretypically introduced into the body cavity by use of a catheter. Thecatheter is usually of the balloon catheter type in which the balloon isutilized to expand the stent, which is positioned over the balloon fordelivery, to place it in a selected location in the body cavity. Thepresent invention is particularly directed to improved arrangements forreleasably attaching and securing the stent to the catheter tofacilitate delivery thereof, specifically having a securement devicewithin the balloon. The below identified embodiments all discloseimproved means for securing the stent to the catheter during thedelivery procedure.

[0011] In certain embodiments the stent is held in place on the catheterby means of an enlarged mounting body carried within the balloon by thecatheter shaft to which the stent and balloon are fitted. The stent isfitted over the balloon, as by crimping. According to the invention insome embodiments, the enlarged body is axially movable on the innershaft of the catheter so that it can be retracted from the stentmounting area to provide a small profile for performing angioplasty. Thecatheter can then be withdrawn; the enlarged body can be moved into thestent mounting area; the stent can be mounted and the catheter can bere-inserted to implant the stent. In other embodiments, the enlargedbody can be arranged to be reducible and enlargeable in size rather thanbeing movable. Alternatively, the movable mounting body may be carriedoutside the balloon. A catheter of this type makes possible a method inwhich, before stent loading with the associated mounting body arrangedto provide reduced diameter in the balloon region, the catheter may beused to dilate a lesion or the like. The catheter may be withdrawn andthe mounting body may then be selectively manipulated to provide anenlarged diameter in the stent mounting region and a stent may be loadedonto the catheter. The catheter may be re-inserted to implant the stent.The catheter may be withdrawn or left in situ and the mounting body maybe manipulated to provide reduced diameter again and the catheter may beused for any post-dilation desired. Also, the catheter may be usedmultiple times in the procedure for dilation and stent implantation.

[0012] Another embodiment of the present invention is also an assemblyfor delivery and deployment of an inflation expandable stent within avessel. The assembly comprises a catheter, an expandable tube componentmounted on the catheter, an expandable balloon mounted on the catheterand encompassing the tube component, and a stent mounted on the balloon.The catheter has proximal and distal ends. The stent is inflationexpandable from a delivery diameter to a deployment diameter. Thedelivery diameter is reduced from the deployment diameter for conformingthe stent to the catheter. The stent, in its delivery diameter, iscoaxially mounted on the catheter near the catheter distal end. Theexpandable balloon is coaxially mounted on the catheter axially withinthe stent. The balloon is designed and adapted for expansion of thestent from the delivery diameter to the deployment diameter uponapplication of fluid deployment pressure to the balloon. The expandabletube component is coaxially mounted on the catheter, axially within theexpandable balloon. The tube components is designed and adapted forfluid expansion to provide a securement pressure to the stent in thedelivery diameter to maintain the stent in position on the catheterduring delivery to the deployment site. The expandable tube component issized and constructed to be fluid expandable to no more than thedelivery diameter. The tube component is essentially equal in length tothe stent and the stent is positioned on the assembly essentiallycoextensive with the tube component.

[0013] In another embodiment, this invention is a method for deliveringand deploying a stent using an assembly as just described. A catheter isprovided having proximal and distal ends. An expandable balloon iscoaxially mounted on the catheter. An expandable tube component iscoaxially mounted on the catheter, axially within the expandableballoon. The balloon and the tube component are each in an unexpandedcondition. A stent is provided which is expandable from a deliverydiameter to a deployment diameter. The stent, in a diameter greater thanthe delivery diameter, is mounted on the balloon. The stent is collapsedto the delivery diameter to conform to an overall profile of thecatheter, the tube component and the balloon. The tube component isinflated to provide to the stent a securement pressure, to retain thestent on the assembly in the delivery diameter. The assembly isdelivered to a deployment site. The balloon is inflated to expand thestent to its deployment diameter.

[0014] An alternative embodiment of present invention is also anassembly for delivery and deployment of an inflation expandable stentwithin a vessel. The assembly comprises a catheter, an expandableballoon mounted on the catheter, a corrugated tubing mounted on thecatheter beneath or within the balloon, and a stent mounted on theballoon. The catheter has proximal and distal ends. The stent isinflation expandable from a delivery diameter to a deployment diameter.The delivery diameter is reduced from the deployment diameter forconforming the stent to the catheter. The stent, in its deliverydiameter, is coaxially mounted on the catheter near the catheter distalend. The expandable balloon is coaxially mounted on the catheter axiallywithin the stent. The balloon is designed and adapted for expansion ofthe stent from the delivery diameter to the deployment diameter uponapplication of fluid deployment pressure to the balloon. The corrugatedtubing is mounted and adhered coaxially onto the catheter and issituated between the balloon and the catheter itself. When the stent iscrimped and loaded onto the balloon, the balloon is situated thereforebetween the stent and the corrugated tubing. The tubing is preferablyessentially equal to the length of the stent and the stent is positionedon the assembly essentially co-extensive with the tube component. Thetubing on the catheter effectively holds the stent in place, takes upthe slack due to recoil and protects the balloon material from beingdamaged during crimping.

[0015] Still another embodiment of the present invention comprises anassembly for delivery and deployment of an inflation expandable stent.The assembly comprises a catheter having proximal and distal ends. Anannular collar or the like is coaxially located on the catheter distalend. A fluid expandable balloon is coaxially mounted over the collar atthe catheter distal end. The balloon is expandable from a contracted toan expanded state. A stent is coaxially mounted on the balloon. Thestent is inflation expandable from a reduced to an enlarged condition,the reduced condition conforming the stent to the balloon, collar andcatheter in the preferred embodiment. The stent has at least an endportion overlying the balloon. At least one cup is coaxially mounted onthe catheter distal end. The cup has a first end portion which mayoverlie the stent end portion. The cup and collar are cooperativelyconstructed and arranged to retain the stent end portion on the catheterin the stent reduced condition when the balloon is in the contractedstate. The balloon and catheter are cooperatively constructed andarranged to cause expansion of the balloon from the contracted to theexpanded state to cause enlargement of the stent, including the stentend portion, from the reduced to the enlarged condition, and therebyrelease the stent end portion from the cup end portion. The cup may beaxially spaced from the collar but preferably they are relatively closetogether. The second end portion of the cup may be fixed to thecatheter. The cup may overlie at least a portion of the collar. Thecollar can be shaped as a single member with the catheter, that isintegral with it or the collar may be a separate body mounted axiallyand positioned on the catheter. The collar may be a mounting ring orcylinder axially positioned between stent end portions under the stentand balloon. The collar may be a sheath under the stent and balloon.

[0016] A further embodiment is also directed to improved arrangementsfor releasably attaching the stent to the catheter to facilitatedelivery thereof. The stent is held in place on the catheter by means ofan enlarged body carried by the catheter shaft within the balloon towhich the stent and balloon are fitted, as by crimping in combinationwith one or more sleeves releasably overlying an end portion or portionsof a stent and balloon.

BRIEF DESCRIPTION OF THE FIGURES

[0017]FIG. 1 is an isometric view, a portion of which is enlarged and inlongitudinal section, of a balloon catheter having a mounting body in aretracted position;

[0018]FIG. 2 is an even more enlarged view in longitudinal cross-sectionof the distal end portion of the catheter of FIG. 1;

[0019]FIG. 3 is similar to FIG. 2 but showing the mounting body advancedto receive a stent mounted on the balloon;

[0020]FIG. 4 is an enlarged cross-sectional view of the distal endportion of the catheter of FIG. 1 similar to that of enlarged view FIG.3 but showing the balloon in an expanded condition along with theexpanded stent;

[0021]FIG. 5 is a schematic showing of a preferred mounting body carriedby the catheter shaft within the balloon, the body being spirally cut toimprove flexibility;

[0022]FIG. 6 is a schematic showing in cross-section of anotherembodiment of the invention with a mounting body positioned to receive astent but with a stent not yet mounted;

[0023]FIG. 7 is a schematic showing of another embodiment of theinvention;

[0024]FIG. 8 is a schematic showing of a means for conveniently crimpingthe stent on the embodiment shown in FIG. 5;

[0025]FIG. 9 is a schematic showing of yet another embodiment of theinvention;

[0026]FIG. 10 is a showing of another embodiment of a mounting bodyaccording to the invention;

[0027]FIG. 11 is a schematic of an enlargeable mounting body which isnot axially movable;

[0028]FIG. 12 is a schematic of an alternate enlargeable mountingarrangement which is not axially movable;

[0029]FIGS. 13 and 14 are schematic showings of yet another embodimentin which the axially movable mounting body is carried outside theballoon;

[0030]FIGS. 15 and 16 are schematic showings of still yet anotherembodiment of the invention, and

[0031]FIGS. 17 and 18 are modified versions of the embodiment shown inFIG. 11.

[0032] FIGS. 19-21 are modified versions of the securement means of thepresent invention.

[0033]FIG. 22 is a side profile section showing a balloon expandablestent delivery and deployment assembly, with the stent crimped todelivery diameter onto the balloon, the underlying inflating componentand the catheter and with the inflating tube component inflated tosecurement pressure.

[0034]FIG. 23 is a side profile section, similar to FIG. 22, with theballoon and the stent fully inflated to deployment diameter.

[0035]FIG. 24 is a side profile section showing an alternativeembodiment of a balloon expandable stent delivery and deploymentassembly, having a tube component formed in several sections.

[0036]FIGS. 25, 26 and 27 are cross-sectional views taken along lines4-4, 5-5 and 6-6 of FIG. 24, respectively.

[0037]FIG. 28 is a side profile section showing a balloon expandablestent delivery and deployment assembly, with the stent crimped todelivery diameter onto the balloon, the underlying tube component andthe catheter.

[0038]FIG. 29 is a side profile section, similar to FIG. 28, with theballoon and the stent fully inflated to deployment diameter.

[0039]FIG. 30 is a perspective view of the corrugated tubing of thepresent invention.

[0040] FIGS. 31-33 are side profile sections showing alternativeembodiments of balloon expandable stent delivery and deploymentassemblies, having the tubing component formed in a plurality ofsections.

[0041] FIGS. 34-35 are side profile sections showing alternativeembodiments of the balloon expandable stent delivery and deploymentassemblies, the tube component inflatable to add securement pressure.

[0042]FIG. 36 is a side profile section showing a balloon expandablestent delivery and deployment assembly, with the stent crimped todelivery diameter onto the balloon, the underlying tube component andthe catheter, and also having containment sleeves covering the ends ofthe stent.

[0043]FIG. 37 is a side profile section showing a balloon expandablestent delivery and deployment assembly, with the stent crimped todelivery diameter onto the balloon, the underlying tube component andthe catheter, and also having a pull-back wire attached to the tubecomponent.

[0044]FIG. 38 is a longitudinal cross-section of a stent delivery anddeployment assembly of this invention showing a catheter with a collarmounted at the catheter distal end, an uninflated balloon mounted on thecatheter over the collar, an unexpanded stent mounted on the balloonabutting the collar and a cup overlying the stent proximal end portion.

[0045]FIG. 39 is a longitudinal cross-section of another stent deliveryand deployment assembly of this invention showing a catheter with acollar mounted as a mounting ring at the catheter distal end, anuninflated balloon mounted on the catheter over the mounting ring, anunexpanded stent mounted on the balloon overlying the mounting ring, anda cup overlying the stent proximal end portion; note that the collar ispositioned closer to the cup than in FIG. 38.

[0046]FIG. 40 is a longitudinal profile in partial cross-section of anassembly similar to that of FIG. 38, with a bulge formed under theuninflated balloon at the catheter distal end.

[0047]FIG. 41 is a longitudinal profile in partial cross-section of theassembly shown in FIG. 38 with the balloon inflated and the stentexpanded, showing the cup end portion flared to release the stent.

[0048]FIG. 42 is a longitudinal profile, similar to FIG. 41, showing thecup end portion rolled proximally to release the stent.

[0049]FIG. 43 is a longitudinal profile of yet another stent deliveryand deployment assembly of this invention, with the balloon mounted onthe catheter, which has a collar formed as a tapered single enlargedpiece on the catheter, an unexpanded stent mounted on the unexpandedballoon abutting the collar and a cylindrical sleeve overlying the stentproximal end portion.

[0050]FIG. 44 is a longitudinal profile of the assembly of FIG. 43 withthe balloon inflated and the stent expanded, showing the sleeve movedproximally to release the stent.

[0051]FIG. 45 is a side profile of still another stent delivery anddeployment assembly of this invention with the uninflated balloonmounted on the catheter which has two collars formed integrally with thecatheter, an unexpanded stent mounted on the balloon abutting the collarand a cylindrical cup overlying the stent proximal end portion and theunderlying collar.

[0052]FIG. 46 is a longitudinal profile of another stent delivery anddeployment assembly of this invention with the uninflated balloonmounted on the catheter, an unexpanded stent mounted on the balloon,mounting a cylinder on the catheter and a pair of cups overlying thestent ends.

[0053]FIG. 47 is an isometric view, a portion of which is enlarged andin longitudinal section, of a balloon catheter having a stent fixed tothe catheter over the balloon;

[0054]FIG. 48 is an even more enlarged view in longitudinalcross-section of the distal end portion of the catheter of FIG. 47;

[0055]FIG. 49 is a schematic showing of one form of retraction of thereleasable sleeve upon expansion of the balloon;

[0056]FIG. 50 is a schematic showing of another form of retraction ofthe releasable sleeve upon expansion of the balloon;

[0057]FIG. 51 is yet another form of retraction of the releasable sleeveupon expansion of the balloon;

[0058]FIG. 52 is a schematic showing of yet another form of retractionof the releasable sleeve upon expansion of the balloon;

[0059]FIG. 53 is a schematic showing of a modified shape for thereleasable sleeve;

[0060]FIG. 54 is a schematic showing in cross-section of anotherembodiment of the invention with a stent not yet mounted;

[0061]FIG. 55 is a schematic showing of another embodiment of theinvention; and

[0062]FIG. 56 is a schematic showing of yet another embodiment of theinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0063] The present invention relates to stent securement devices, mostnotably positioned between the balloon and the inner shaft of thecatheter. Individual elements of the below disclosed embodiments aregenerally interchangeable if desired. Referring to FIGS. 1-4 anangioplasty and stent delivery catheter system generally indicated at 10includes a balloon catheter 12 having a balloon 14 on a distal endportion generally indicated at 16. FIG. 1 shows a proximal portion ofthe catheter at 12 a and a distal portion 12 b in enlarged view. FIGS. 2and 3 show the distal end portion 16 in an even more enlarged view. Theillustrative catheter 12 is of the type known as a rapid exchange orsingle operator catheter. However, other types of catheters may be used,such as over the wire and fixed wire types. The balloon 14 is fixed tothe catheter 12 by standard means. The balloon is shown in itscontracted state in. A stent 18 is fixed about the balloon by crimpingthereto. The stent has a larger expanded diameter which is obtained whenthe balloon is expanded in the known manner. In FIGS. 1 and 2 catheteris shown prepared for performing angioplasty and in FIG. 3 it isprepared for stent implantation.

[0064] In FIGS. 1 and 2, an axially movable mounting body 30 is shown ina position proximal to the end portion 16 of the catheter where a stentmay be mounted. The catheter includes at its proximal end a manifold,generally designated 13, as is known in the art. The manifold includesan inflation port 15 as is known in the art. A wire 31 is attached tobody 30 to enable remote (from the proximal catheter end) advancementand retraction of it axially on inner lumen 26 over which it slides. Inthe retracted position shown in FIGS. 1 and 2, the catheter has a lowprofile for performing angioplasty.

[0065] This position is a retracted position and is selected byoperation of a pull wire 31. The retracted position of the mounting bodymay vary. To maximize the low profile of the distal end 16 of thecatheter, the retracted position may be within the outer member 24.

[0066] After such a procedure, the balloon is deflated, the catheter iswithdrawn and the mounting body is advanced by means of wire 31 to thestent mounting position shown in FIG. 3. A stent 18 may then be fixedabout the deflated balloon by crimping it thereto. The stent has alarger expanded diameter which is obtained when the balloon is againexpanded in the known manner. That is, the stent is released from thecatheter upon expansion of the balloon as shown in FIG. 4 to be placedin a vessel at the desired location. When the balloon is then againdeflated, removal of the balloon and catheter may be accomplished,leaving the stent in place. Exemplary dimensions for the inner 26 is adiameter of ½ mm and for body 30 a diameter of ¾ mm.

[0067] As is known in the art the balloon is either bonded at its endsby adhesive 20 and 22, respectively to the outer member 24 of thecatheter and to the inner member 26 of the catheter in the manner asshown, or is made one-piece with the outer member as is known in theart. The catheter balloon may be inflated by fluid (gas or liquid) froman inflation port extending from a lumen 28 (seen in FIG. 2 and 3)contained in the catheter shaft and opening into the balloon as shown,or by other known arrangements, depending on the design of the catheter.The details and mechanics of balloon inflation and specific overallcatheter construction will vary according to the particular designinvolved in any given instance, and are known in the art per se. Suchdetails are only shown schematically herein. All variations areacceptable for use with this invention.

[0068] Any balloon expandable stent may be used with this invention.Many are known in the art including plastic and metal stents. Some aremore well known such as the stainless steel stent shown in U.S. Pat. No.4,735,665; the wire stent shown in U.S. Pat. No. 4,950,227; anothermetal stent shown in European Patent Application EP0 707 837 A1 and thatshown in U.S. Pat. No. 5,445,646, or U.S. Pat. No. 5,242,451. All ofthese patents are incorporated herein by reference. Also, shape memorymetal stents may be used. As already indicated the stent of PCTApplication 960 3092 A1 is particularly preferred.

[0069] The stent is typically for example about 16 mm long, while theballoon may be 20 mm long for example. These dimensions, however, aremerely representative for illustrative purposes only and are not meantto be limiting. The stent is positioned over the balloon portion of thedilatation catheter and gently crimped onto the balloon either by handor with a tool such as a pliers or the like to be mounted for deliveryas shown in FIG. 3. The crimping may be readily accomplished by thephysician during the procedure.

[0070] In accordance with this invention, mounting body 30, best seen inFIGS. 2 and 3, is included inside balloon 14 to provide a cushion and/orsubstrate of enlarged diameter relative to the stent to support and holdthe stent and secure it during crimping and the delivery procedure. Themounting body may be axially movable proximally or distally from theposition shown in FIG. 3, proximally being preferred.

[0071] In the embodiment shown in FIGS. 1-3, mounting body 30 iscylindrical in form and takes the shape of a sleeve axially and slidablycarried on inner lumen 26, providing an enlarged area or portion forreceiving the balloon and stent when the latter is crimped to theballoon. Marker band 34 may also be included on inner 26 as shown. Anyradiopaque material such as gold is useful for this purpose. A stopmember 36 of generally conical shape or any other shape may also beincluded on the marker band 34 as shown to provide additional resistanceto stent movement during delivery and to protect the leading edge of thestent during delivery. Polyethylene or the like is suitable for the stopmember. Other marker arrangements and stop arrangements may be used aswell.

[0072] Although, the material of the mounting body may be hard, it ispreferably of any deformable thermoplastic material, preferably anelastomer material and more preferably of a relatively resilientelastomer material, e.g., lower durometer silicone. A preferreddeformable thermoplastic material is high density polyethylene (HDPE). Apreferred lower durometer silicone is in the form of tubing. Thedeformation of the resilient material of the mounting body when thestent/balloon is crimped to it causes a radial outward force on thestent/balloon increasing the friction therebetween despite any recoil ofthe stent.

[0073] During stent delivery, the balloon catheter is advanced throughand positioned in a patient's vasculature so that the stent is adjacentto the portion of the vessel where treatment is to take place. Theballoon is inflated to expand the stent to an enlarged diameter. Whenthe stent has reached the desired diameter, the balloon is deflated sothat the catheter may be removed leaving the stent in place.

[0074] Another embodiment of the invention is shown in FIG. 5. In thisembodiment mounting body 30 is a spiral cut elastomer or other suitablematerial, such as a rigid or flexible plastic, to provide separation forflexibility in that portion of the catheter, allowing more easy movementor tracking around bends. The spiral cut may be only partly through themounting body or may be all the way through as shown in FIG. 5. Also,while stop member 36 is shown at the distal end portion of the catheterin this embodiment, no stop member may be used.

[0075] Another similar version is shown in FIG. 6 which includes acylindrical mounting body 30 made up of a plurality of separate adjacentrings 30 a held together by wire 31 which extends therethrough as shownwith stops 29 to secure the rings together. Rings 30 a may be individualbodies carried on the sheath or bodies cut from a cylinder to partiallyseparate them or fully separate them. Suitable arrangements may be madeto wire 31 at each end of the body 30 to hold the rings together, asshown.

[0076] The embodiment shown in FIG. 7 includes another feature based onthe geometry of the mounting body for further securing the stent uponcrimping. This feature is referred to herein as “interlocking”. That is,the stent may be interlocked to the mount so that the stent cannot slideproximally or distally on the balloon unless it is deformed, such as byexpansion. This can be seen by perusing the structure shown in FIG. 7which includes the inner 26 having a two-piece mounting body made up ofspaced mounting bodies 30 a and 30 b. These bodies are connected to eachother by connection means 33 which may be a separate or integralcylindrical body of lesser diameter or may be one or two or morerelatively rigid wire members as shown. The spacing between bodies 30 aand 30 b allows portions of the stent 18 and balloon 14 to be depressedor inserted between the bodies upon crimping of the stent thus formingan interlock against sliding of the stent axially or longitudinallybefore the stent is released.

[0077] The interlock formation or crimping is readily accomplished byany suitable means such as a two-piece die 40 shown in FIG. 8 or thelike.

[0078]FIG. 9 demonstrates that more than a two-piece mounting bodyarrangement may be used if desired. In this embodiment, the mountingbody is comprised of three spaced interconnected bodies 30 a, 30 b and30 c on the inner 26. Preferably in the embodiments of FIGS. 7 and 9,the mounting bodies will be ring-like in shape or cylindrical in shapealthough other configurations will be readily apparent to those familiarwith this art.

[0079] Referring now to FIG. 10, another embodiment of a movablemounting body 30 is shown in the form of a rigid coil of plastic, metalor the like having a control wire 31, preferably integral therewith.When in the metal form, the coil may be coated with a polymer such aspolyethylene or PTFE or enclosed in a polymeric sheath of similarmaterial. The coil may be slidably received on the inner 26 similar inarrangement to that shown in the preceding Figures.

[0080] As already indicated, an alternate arrangement may be used inwhich the mounting body, instead of being movable, is designed to beenlargeable and reducible or collapsible, while remaining in a fixedposition in the stent mounting area of the catheter. FIGS. 11 and 12 aredirected to such an arrangement.

[0081] In FIG. 11, an inner balloon 50 of smaller diameter than outerballoon 14 is mounted on the inner 26. Balloon 50 may have a separateinflation conduit 52 inside inner 26, preferably including a valvingarrangement 54. Valve 54 may be a one-way valve allowing only inflationof balloon 50 if desired. However, inner 26 may serve as the inflationconduit as well. In addition to fully inflating the balloon, innerballoon 50 may also be partially inflated.

[0082]FIG. 19 shows a modification to FIG. 11 in which two innerballoons 50 a and 50 b are included. FIG. 20 shows a modification inwhich two inflation valves 54 a and 54 b are included.

[0083]FIG. 21 shows a full arrangement of inner balloon 50 in which asyringe 120 is inserted into the distal end of the liner 26 of thecatheter. The syringe has at its ends blocks 122 and 124 to enable localpressurization of inner 26 to inflate balloon 50.

[0084]FIGS. 17 and 18 show an inner balloon 50 similar to thearrangement of FIG. 11 but the balloon 50 in FIG. 17 has a narrow centerportion and wide ends to provide a mounting shape similar to that ofFIG. 7. In FIG. 17, balloon 50 is inflated and balloon 14 is partiallyinflated. In FIG. 18, balloon 50 is inflated and balloon 14 isuninflated ready for stent loading. Balloon material is preferably apolyethylene or urethane elastomer such as Tecoflex or Tecothane fromThermedics.

[0085] Referring to FIG. 12, an alternate embodiment is shown in whichthe proximal portion of the inner 26 is axially movable while the distalportion 26 b is fixed with respect to the catheter. In between portion26 a and portion 26 b is a coil spring 60 inside a flexible sheath 62 ofPTFE or the like. Portion 26 b of the inner is attached to balloon 14 atthe very distal end portion of the catheter. Portion 26 a is movableaxially within the outer 22. Thus, if 26 a is pushed in the distaldirection and held to compress coil 60, the coil will enlarge indiameter to provide an enlarged mounting area for a stent. Twisting theinner to twist the coil will enhance enlargement. Alternatively, coilspring 60 may be replaced by a braided element.

[0086] Also, by providing different pitch over the length of the coil itcan be made to enlarge more in some regions than in others. For example,if the coil windings are closer together in the center portions than inthe end portions, when the coil undergoes compressing, the two endportions will enlarge in diameter more than the center portion toprovide a mount similar to that of FIG. 7.

[0087] Referring now to FIGS. 13 and 14, another embodiment is shownwhich is alternative to the earlier described embodiments which areinside the balloon on the catheter. In this embodiment a sheath 80 iscarried on the outside of the catheter. Sheath 80 is elastomeric and isaxially movable from a stent mounting position as shown in FIG. 14 to aposition remote from the stent mounting position, such as the retractedposition as shown in FIG. 13. In the position shown in FIG. 13, balloon14 may be inflated and deflated. In the position shown in FIG. 14,balloon 14 will be deflated for low profile. Sheath 80 when over theballoon as in FIG. 14 acts to increase the profile of the catheter tofacilitate crimping a stent thereto during deployment of the stent,sheath 80 will expand with balloon 14 to facilitate inflation and duringdeflation the elastomer sheath will return to its original dimension. Anelastomer material which is presently preferred is Tecothane, a tradename for a thermoplastic polyurethane available from Thermedics, Inc.,of Woburn, Mass. It may be about 0.003 inches thick, for example.

[0088] With respect to FIGS. 15 and 16, a further embodiment of theinvention is shown in which inner 26 carries a mounting body 30, thedistal end 100 of which is secured or fixably attached to inner 26, asby any suitable adhesive. The remainder of body 30 is slidable overinner 26 as by the application of compression in the distal direction atthe proximal end 102. This may be accomplished by push wire 104 whichextends to the proximal end of the catheter for remote manipulation asis known in the art.

[0089] Mounting body 30 is accordion folded with more widely spacedfolds at the end portions 106, than at the central portion 108. Thus, ascan be seen in FIG. 15, a relatively low profile is provided withoutcompression for normal angioplasty use. When a stent is to be mounted(not shown), compression by means of push wire 104 will result in aconfiguration of enlarged diameter of body 30 as shown in FIG. 16 toprovide a mount similar to that of FIG. 7 in general configuration. Ifthe spring is uniform over the body, it sill enlarge uniformly, similarto the inner balloon of FIG. 11. The Figures are schematic in form butthe concept can be readily appreciated.

[0090] As an alternative to a folded construction, the body may be ofbraided construction to achieve the same operation.

[0091] Also, this form of body 30 may be inserted into a two piece inner26 similar to the arrangement shown in FIG. 12. In all of thesearrangements, the accordion folded body material may be of any suitablepolymer, such as polyethylene. For example, tubing having a wallthickness of about 0.002 inches may be used. The accordion folds orpleats may be readily formed in such tubing by means of a pressure moldcontaining spaced blades placed in a heated chamber.

[0092] FIGS. 22-27 show embodiments wherein the inner securement devicecomprises an inner balloon beneath the outer catheter balloon, similarto above. FIGS. 22 and 23 illustrate a side profile section showing aninflation expandable stent delivery and deployment assembly generallydesignated 110. Assembly 110 includes a catheter comprised of innershafts 112 and 113 and an outer shaft 115 of the coaxial type, aninflation expandable balloon 114, an inflation tube component 116 suchas an inner balloon and inflation expandable stent 118. Any conventionaltype of catheter may be used, such as a catheter of the type generallyused for PTA or PTCA angioplasty procedures, for prostate therapy, andTTS endoscopic catheters for gastrointestinal use. However, coaxialtypes as shown are most preferred. The particular catheter 112 shown isformed of a biocompatible and hydrophilic compatible material, such as alubricous polyimide or polyethylene. Other suitable materials for thecatheter 112 include nylons, urethanes, and polypropylene materialscompatible with coatings such as silicone and/or hydrophilic coatings.In addition to hydrophilic compatible materials, any biocompatiblematerial may be used. For example, polyethylene or polypropylene can becoated with a hydrophilic material to render them hydrophiliccompatible. Suitable catheters for use according to the presentinvention include a number of catheters available from SciMed LifeSystems, Inc., Maple Grove, Minn., the assignee of the presentinvention, such as BANDI™, COBRA™, VIVA™, and VIVA PRIMO™ catheters.

[0093] Inflatable tube component 116 is fixed at its distal and proximalend to inner shaft 112 and at its proximal end to inner shaft 113 at aposition to be encompassed within the distal and proximal ends of theouter balloon 114. According to art-recognized convention, the lengthL-B of the balloon 114 is defined as the length of the body portion ofthe balloon 114, excluding the terminal cone sections 120. As seen inFIG. 23, the body portion of the balloon 114 is generally cylindricalwhen in its deployed or inflated condition. Tube component 116 isillustrated as having terminal sections 122 which are more relativelyvertical than the cone sections 120 illustrated for the balloon 114.However, it is to be understood that, according to the presentinvention, either of the terminal sections 120, 122 may be relativelycone shaped, relatively vertical or of any other configuration known tothose of skill in this art. A preferred length L-T of the tube component116 is illustrated in FIGS. 22 and 23 as substantially equal to thelength L-B of balloon 114, and substantially equal to the length L-S ofstent 112. However, according to the present invention, stent 112 shouldbe supported by the underlying tube component 116 for a lengthsufficient to permit accomplishment of the stated purpose of the tubecomponent 116, when inflated, to provide securement pressure for stent112 to maintain stent 1 12 in position with assembly I 10 duringdelivery. It is also within the present invention for tube component 116to be slightly shorter than stent 112, for example, the distal end 119of stent 112 may extend distally beyond the distal end 121 of tubecomponent 116 (not shown), so that the distal end 119 of stent 121 canbe crimped over the distal end 121 of tube component 116 to prevent thedistal end 119 of stent 112 from catching and tending to further open asit is maneuvered within a body vessel. As has been explained above, tubecomponent 116 is designed and constructed to be inflatable to no morethan is necessary to compensate for recoil crimping of stent 112 and toclosely accommodate (or even slightly over-stress) the delivery diameterof stent 112, taking into consideration the thickness of the interveninguninflated balloon 114. Tube component 116 is inflated through theopening(s) 117 of inner shaft 112. Typically, tube component 116 willhave a wall thickness of about 0.0002-0.0007 inch and will be inflatableto no more than about 0.035.-0.045 inches.

[0094] Inflating tube component 116 may be formed of either compliant ornoncompliant balloon materials. Compliant materials include lowpressure, relatively soft or flexible polymeric materials, such asthermoplastic polymers, thermoplastic elastomers, polyethylene (highdensity, low density, intermediate density, linear low density), variousco-polymers and blends of polyethylene, ionomers, polyesters,polyurethanes, polycarbonates, polyamides, poly-vinyl chloride,acrylonitrile-butadiene-styrene copolymers, polyether-polyestercopolymers, and polyetherpolyamide copolymers. Suitable materialsinclude a copolymer polyolefin material available from E.I. DuPont deNemours and Co. (Wilmington, Del.), under the trade name Surlyn™ Ionomerand a polyether block amide available under the trade name PEBAX™.Non-compliant materials include relatively rigid of stiff high pressurepolymeric materials, such as thermoplastic polymers and thermosetpolymeric materials, poly(ethylene terephthalate) (commonly referred toas PET), polyimide, thermoplastic polyimide, polyamides, polyesters,polycarbonates, polyphenylene sulfides, polypropylene and rigidpolyurethanes.

[0095] A balloon 114 for use according to the present invention may beany conventional balloon for catheter delivery, such as a balloon of thetype generally used for PTA and PTCA procedures. Typically, balloon 114is fixed at its distal end to inner shaft 112 near the catheter distalend and at its proximal end to outer shaft 115. Balloon 114 is larger indiameter than tube component 116, because balloon 114 must be able toexpand to a larger diameter than tube component 116. Balloon 114 isinflatable through an inflation conduit 123, i.e., the space betweencoaxial inner shaft 113 and outer shaft 115 of the catheter. The distaland proximal ends of balloon 114 are shown in FIGS. 22 and 23 positionedexterior to the distal and proximal ends of tube component 116,respectively, and of a length L-B generally equal to the length L-T ofthe tube component 116. To be compatible with tube component 116illustrated in FIGS. 22 and 23 and described above, balloon 114 isinflatable at deployment to about the diameter of the body vessel inwhich the stent 118 is to be deployed. Balloon 114 may be formed of acompliant or non-compliant material, of the types of compliant materialsdescribed herein above, such as polyethylene or any standard balloonmaterial. Balloon 114 typically has a wall thickness of about0.0007-0.004 inch for example.

[0096] A stent for use according to the present invention may be anyconventional type of balloon expandable stent, including stents of thetype used for PTA and PTCA angioplasty procedures, for prostate therapy,and TTS endoscopic catheters for gastrointestinal use. Suitable stentmaterial is biocompatible stainless steel in the form of sheet metal,tube component wire or Nitinol. A preferred stent is described in PCTApplication No. 960 3072 A1, published 8 Feb. 1996, the content of whichis incorporated herein by reference. All such stents are well known inthis art generally and additional examples are described in U.S. Pat.No. 5,507,768 to Lau et al.; in U.S. Pat. No. 5,458,615 to Klemm et al;in U.S. Pat. No. 5,226,889 to Sheiban; in U.S. Pat. No. 4,875,480 toImbert; in U.S. Pat. No. 4,848,343 to Wallsten et al., and in U.S. Pat.No. 4,733,665 to Palmaz. Stent 18 as shown in FIGS. 22 and 23 ispositioned on balloon 114, the underlying inflatable tube component 116and the distal end of the catheter. The length L-S of stent 118 is shownas essentially equal or slightly smaller than the length L-T of tubecomponent 116 and is positioned on assembly 110 to be co-extensive withtube component 116. In this position, stent 118 is shown in FIG. 22crimped to its delivery diameter D1, which is about 0.035-0.045 inch forexample.

[0097] As discussed above, despite the most careful and firm crimping ofstent 118 to closely conform to the overall profile of the catheterunexpanded balloon 114 and underlying inflatable tube component 116,there is a certain amount of “recoil” of stent 118 or a tendency ofstent 118 to slightly open from a desired hypothetical minimum crimpeddiameter. The actual minimum diameter achievable for fully crimped stent118 on assembly 110 is referred to as the stent 118 delivery diameterD1. This tendency of stent 118 to open or recoil slightly when crimpedon assembly 10 has been characterized as “recoil crimping”. In FIG. 22,inflatable tube component 116 is shown inflated to a diameter which isgenerally sufficient to compensate for any slack or looseness betweencrimped stent 118 and the overall profile of the catheter, theunexpanded balloon 114 and the underlying inflatable tube component 116due to recoil crimping.

[0098]FIG. 23 illustrates a side profile section showing a stentdelivery and deployment assembly 110 of this invention with balloon 114fluid inflated to its fully expanded position. As a result of the fluidinflation of the balloon 114, stent 118 has also been fully expanded toits deployment diameter D2 in which it can be deployed against the wallsof a body vessel in which it is situated.

[0099] Tube component 116 may have a shape other than the cylindricalshape described and illustrated with regard to the embodiment shown inFIGS. 22 and 23. Further, the tube component may be comprised of morethan one separately inflatable pouch. For example, as illustrated withregard to FIG. 24, the tube component of an alternative stent deliveryand deployment assembly generally designated 130 can be comprised ofthree separately inflatable pouches 136, 138, 140. The pouches 136, 138,140 are each separately inflatable through their respective inflationconduits 137, 139 141, and each of the pouches 136, 138, 140 can beinflatable to a different extent. The conduits are formed in the wall ofshaft 132 as can be seen in FIGS. 25-27. The stent delivery anddeployment assembly 130 of FIG. 24 is also comprised of a catheterhaving inner shaft 132 and outer shaft 135, a balloon 134, with itsballoon inflation conduit 139 and the balloon terminal cone sections144, and a stent 142. As has been explained above with reference toFIGS. 22 and 23, stent 142 is crimped to closely conform to the overallprofile of the catheter the unexpanded balloon 134 and the underlyinginflatable pouches 136, 138, 140. Even with the most careful and firmcrimping, there is a certain amount of “recoil” of the stent 142 or atendency of stent 142 to slightly open from a desired hypotheticalminimum diameter. In FIG. 24, the first 136 and third 140 pouches areinflated to a slightly larger size than the second pouch 138. Asdiscussed above, the inflation of the pouches 136, 138, 140 to thisconfiguration is generally sufficient to compensate for any slack orlooseness between the crimped stent 142 and the overall profile of thecatheter, the unexpanded balloon 134 and the underlying inflatablepouches 136, 138, 140 due to recoil crimping. Once pouches 136, 138 140have been inflated to the configuration shown in FIG. 24, stent 142 isfirmly secured against axial movement with regard to assembly 130. Thedistal 146 and proximal 148 ends of stent 142 are protected from anypossible unwanted contact with vessel walls during maneuvering, whichhelps to protect the vessel walls from abrasion and also helps toprotect the ends 146, 148 of stent 142 from distortion. Additionally,stent 142 may be of a length such that it fits over pouch 140 and pouch13 6 as well as over pouch 138.

[0100] The method of using the stent delivery and deployment assembly110 of this invention, as shown in FIGS. 22 and 23, is described asfollows. The assembly 110 is constructed as described above. Stent 118is compressed or crimped onto balloon 114, inflatable tube component 116and the catheter to a delivery diameter D1. This crimping can be donemanually or with the aid of tooling specially designed for the purposeeither by the physician or the manufacturer. In the crimped position,stent we closely conforms to the overall profile of balloon 114,inflatable tube component 116 and the catheter except for the slightslack or looseness due to recoil crimping. Tube component 116 is fluidinflated to the extent necessary to compensate for this slack orlooseness due to recoil crimping. The pressure of force required toinflate tube component 116 to this extent is also referred to assecurement pressure, i.e., the force or pressure needed to secure stent112 in this position. It is to be noted that, since tube component 116is designed and constructed to be capable of fully expanding to no morethan the size necessary to compensate for recoil crimping, there is nopossibility of stent 112 expanding or beginning to open to a largerdiameter. Thus, there is no hazard of stent 112 moving out of itsposition on the catheter during delivery or of becoming separated fromthe catheter within a body vessel. The catheter distal end is deliveredby standard techniques to the deployment site within the body vessel ofinterest. At this point, stent 112 is positioned as required by thephysician and balloon 114 is fluid inflated by standard technique toexpand stent 121 to its deployment diameter D2. During this expansion,stent 112 is expanded to fill the body vessel. Following deployment ofstent 112, balloon 114 and optionally, tube component 116 are deflatedand the assembly 110 is retracted proximally and withdrawn from thebody. If required by the procedure, the site of entry to the body isappropriately closed.

[0101] The method of using the stent delivery and deployment assembly130 of this invention, as shown in FIG. 24, is similarly described. Theassembly 130 is constructed as described above. Stent 142 is compressedor crimped to closely conform to the overall profile of balloon 134,inflatable pouches 136, 138, 140 and the catheter except for the slightslack or looseness due to recoil crimping. Pouches 136, 138, 140 areeach fluid inflated to the profile shown in FIG. 24 through separatefluid inflation conduits (not shown) to securement pressure tocompensate for this slack or looseness and to secure stent 142 in thisposition. The overall configuration of pouches 136, 138 140 furtherserves to position stent 142 against axial dislocation during delivery.The catheter is delivered by standard techniques to the deployment sitewithin the body vessel of interest. At this point, stent 142 ispositioned as required by the physician and balloon 134 is fluidinflated by standard technique to expand and deploy stent 142. Followingdeployment of stent 142, balloon 134 and, optionally, pouches 136, 138140 are deflated and the assembly 130 is retracted proximally andwithdrawn form the body. If required by the procedure, the site of entryto the body is appropriately closed.

[0102] The inflation tube component provided by this invention maximizesstent securement force by optimizing the frictional force between theinflating tube component, the balloon wall and the internal diameter ofthe stent in its reduced crimped delivery diameter. The inflation tubecomponent is more flexible than a solid sheath under the expandableballoon, and thus the entire assembly has greater flexibility. Thisinvention has particular advantages for assemblies in which the stent isprovided for use as pre-crimped to the balloon and underlying catheter,by increasing the shelf life of the pre-crimped assembly. The featuresand principles described for this invention are suitable for use withfixed wire, over-the-wire and single operator exchange assemblies.

[0103] FIGS. 28-37 disclose still further embodiments of the securementdevice. FIGS. 28 and 29 illustrate a side profile section showing aninflation expandable stent delivery and deployment assembly, generallydesignated 210. Assembly 210 includes a catheter comprised of innershaft 212 and outer shaft 213 of the coaxial type and an optionalretractable delivery shaft 211 (typically called a guide catheter, shownretracted in FIG. 29, an inflation expandable balloon 214, acorrugated/ribbed stent securement device 216, optional marker bands 217and an inflation expandable stent 218. Any conventional type of cathetermay be used, such as a catheter of the type generally used for PTA orPTCA angioplasty procedures, for prostate therapy, and TTS endoscopiccatheters for gastrointestinal use. However, coaxial types as show aremost preferred. The particular catheters 212 and 213 shown are formed ofa biocompatible and hydrophilic compatible material, such as a lubricouspolyimide or poly ethylene. Other suitable materials for the catheters212 and 213 include nylons, urethanes, and polypropylene materialscompatible with coatings such as silicone and/or hydrophilic coatings.In addition to hydrophilic compatible materials, any biocompatiblematerial may be used. For example, polyethylene or polypropylene can becoated with a hydrophilic material to render them hydrophiliccompatible. Suitable catheters for use according to the presentinvention include a number of catheters available from SciMed LifeSystems, Inc., Maple Grove, Minn., the assignee of the presentinvention, such as BANDIT™, COBRA™, VIVA™, VIVA PRIMO™, MAXXUM™, MAXXUMENERGY™ and RANGER™ catheters.

[0104] Securement device 216 is fixed at its distal and/or proximal endsto inner shaft 212 at a position to be encompassed within the distal andproximal ends of the outer balloon 214. According to art-recognizedconvention, the length L-B of the balloon 214 is defined as the lengthof the body portion of the balloon 214, excluding the terminal conesections 220. As seen in FIG. 29, the body portion of the balloon 214 isgenerally cylindrical when in its deployed or inflated condition.Securement device/tube component 16 is illustrated as having terminalsections 221,222. It is to be understood that, according to the presentinvention, either of the terminal sections 220, 222 may be relativelycone shaped, relatively vertical, relatively flat or of any otherconfiguration known to those of skill in this art. A preferred lengthL-T of the tubing 216 is illustrated in FIGS. 28 and 29 as substantiallyequal to the length L-B of balloon 214, and substantially equal to thelength L-S of stent 218. However, according to the present invention,stent 218 should be supported by the underlying tube component 216 for alength sufficient to permit accomplishment of the stated purpose of thetube component 216, to provide a superior securement and protectivesurface for stent 218 to maintain stent 218 in position with assembly210 and to protect the balloon material during loading/crimping. It isalso within the present invention for the tube component 216 to beslightly shorter than stent 218, for example, the distal end 219 ofstent 218 may extend distally beyond the distal end 21 of tube component216 (not shown), so that the distal end 19 of stent 18 can be crimpedover the distal end 221 of tube component 216 to prevent the distal end221 of stent 218 from catching and tending to snag or further open as itis maneuvered within a body vessel. As has been explained above, tubecomponent 216 is designed and constructed to have enough flexibility andhave enough volume to no more than is necessary to compensate for recoilcrimping of stent 218 and to closely accommodate (or even slightly overstress) the delivery diameter of stent 218, taking into considerationthe thickness of the intervening uninflated balloon 214. Typically, thetube component 216 will have a consistent frequency of ribs, but mayalso vary by having intermittent groups of ribs along the tubing.

[0105] The balloon and the crimped stent slightly conform to theundulations of the tube component for greater securement, but thisconformation is not illustrated.

[0106] Tube component 216 may be formed from a thermoplastic material,preferably a low modulus polymer, such as Surlyn™, Pebax and urethane.The device such as polypropylene, low density polyethylene (LDPE), highdensity polyethylene (HDPE), ethylene vinyl acetate (EVA), nylon,polyester and polyethylene terephthalate (“PET”), may be preparedthrough free blowing in a mold or inside a coil. Tubing is extruded withrelatively thin walls and then free-blown in a mold, coil or otherfixture to form the ribs/corrugation.

[0107] A balloon 214 for use according to the present invention may beany conventional balloon for catheter delivery, such as a balloon of thetype generally used for PTA and PTCA procedures.. Typically, balloon 214is fixed at its distal end to inner shaft 212 near the catheter distalend and at its proximal end to inner shaft 212, near the distal end ofthe outer shaft 213. Balloon 214 is inflatable through an inflationconduit 223, i.e., the space between coaxial inner shaft 213 and outershaft 213 of the catheter. The distal and proximal ends of balloon 214are shown in FIGS. 28 and 29 positioned exterior to the distal andproximal ends of tube component 216, respectively, and of a length L-Bgenerally equal to the length L-T of the tube component 216. To becompatible with the tube component 216 illustrated in FIGS. 28 and 29and described above, balloon 214 is inflatable at deployment to aboutthe diameter of the body vessel in which the stent 218 is to bedeployed. Balloon 214 may be formed of a compliant or non-compliantmaterial, such as polyethylene or any standard balloon material.Compliant materials include low pressure, relatively soft or flexiblepolymeric materials, such as thermoplastic polymers, thermoplasticelastomers, polyethylene (high density, low density, intermediatedensity, linear low density), various co-polymers and blends ofpolyethylene, ionomers, polyesters, polyurethanes, polycarbonates,polyamides, polyvinyl chloride, acrylonitrile-butadiene-styrenecopolymers, polyether-polyester copolymers, and polyetherpolyamidecopolymers. Suitable materials include a copolymer polyolefin materialavailable from E.I. DuPont de Nemours and Co. (Wilmington, Del.), underthe trade name Surlyn™ Ionomer and a polyether block amide availableunder the trade name PEBAX™. Non-compliant materials include relativelyrigid stiff high pressure polymeric materials, such as thermoplasticpolymers and thermoset polymeric materials, poly(ethylene terephthalate)(commonly referred to as PET), polyimide, thermoplastic polyimide,polyamides, polyesters, polycarbonates, polyphenylene sulfides,polypropylene and rigid polyurethanes, or combinations thereof. Theballoon 214 typically has a wall thickness of about 0.0007-0.004 inchfor example.

[0108] A stent for use according to the present invention may be anyconventional type of balloon expandable stent, including stents of thetype used for PTA and PTCA angioplasty procedures, for prostate therapy,and TTS endoscopic catheters for gastrointestinal use. Suitable stentmaterial is biocompatible stainless steel in the form of sheet metal,tube component wire or Nitinol. A preferred stent is described in PCTApplication No. 960 3072 A1, published 8 Feb. 1996, the content of whichis incorporated herein by reference. All such stents are well known inthis art generally and additional examples are described in U.S. Pat.No. 5,507,768 to Lau et al.; in U.S. Pat. No. 5,458,615 to Klemm et al.;in U.S. Pat. No. 5,226,899 to Sheiban; in U.S. Pat. No. 4,875,480 toImbert; in U.S. Pat. No. 4,848343 to Wallsten et al.; and in U.S. Pat.No. 4,733,665 to Palmaz. Stent 218 as shown in FIGS. 28 and 29 ispositioned on balloon 214, which is over the underlying tube component216, at the distal end of the catheter. The length L-S of stent 218 isshown as essentially equal or slightly smaller than the length L-T oftube component 216 and is positioned on assembly 210 to be coextensivewith tube component 216. In this position, stent 218 is shown in FIG. 28crimped to its delivery diameter D1, which is about 0.035-0.45 inch forexample.

[0109] As discussed above, despite the most careful and firm crimping ofstent 218 to closely conform to the overall profile of the catheterunexpanded balloon 214 and underlying tube component 216, there is acertain amount of “recoil” of stent 218 or a tendency of stent 218 toslightly open from a desired hypothetical minimum crimped diameter. Theactual minimum diameter achievable for fully crimped stent 218 onassembly 210 is referred to as stent 218 delivery diameter D1. Thistendency of stent 218 to open or recoil slightly when crimped onassembly 210 has been characterized as “recoil crimping”. In FIG. 28,tube component 216 is shown inflated to a diameter which is generallysufficient to compensate for any slack or looseness between crimpedstent 218 and the overall profile of the catheter, the unexpandedballoon 214 and the underlying tube component 216 due to recoilcrimping.

[0110]FIG. 29 illustrates a side profile section showing a stentdelivery and deployment assembly 210 of this invention with balloon 214fluid inflated to its fully expanded position. As a result of the fluidinflation of the balloon 214, stent 218 has also been fully expanded toits deployment diameter D2 in which it can be deployed against the wallsof a body vessel in which it is situated.

[0111]FIG. 30 illustrates the preferred configuration of the tubecomponent 216. The tube component has a plurality of ribs 230 and isconfigured in a corrugated or accordion fashion. The ends of the tubecomponent 216, 222 and 221, are substantially rib-free so as to providea flat surface to receive an adhesive and thereby bond to the innershaft 212. Preferable adhesives include cyanoctylates such as Loctite4061/4011 or urethanes, such as H.B. Fuller 3507/3506. The tubecomponent may also be heat bonded to the inner shaft. The ribs may varyin frequency and spacing.

[0112] Tube component 216 may have different configurations in otherembodiments, as shown in FIGS. 31-33. The tube component 216 may becomprised of more that one piece of corrugated tubing (FIG. 31), asmaller single piece (FIG. 32) or one single piece of tubing sectionedinto a plurality of ribbed sections, wherein the tubing is adhered tothe inner shaft 212 in more than two locations (FIG. 33).

[0113]FIG. 31 shows two pieces of tubing component 216 a, 216 b. Bothpieces are adhered to inner shaft 212 at adhesion points 232. FIG. 32discloses an embodiment which comprises one smaller piece of tubecomponent 216 which is adhered to inner shaft 212 at adhesion points232. FIG. 33 discloses an embodiment which comprises one tube component216 which has interrupted ribbed sections 234 adhered to the inner shaft212.

[0114]FIGS. 34 and 35 illustrate an alternative embodiment in which thetubing component is inflatable to increase the securement pressure onthe inside of balloon 214 when the stent is crimped onto the balloon soas to negated additional recoiling. The full expansion of the tubecomponent 216 should only be slightly greater than the diameter of theinside of the balloon 214 when the stent 218 is fully crimped onto theballoon 214.

[0115] In FIG. 34, the inflating fluid comes through the guide wirelumen 212 under pressure from the proximal end or the distal end of theguide wire lumen 212, preferably via a syringe, and fills the tubingcomponent 216 through a one-way valve 247 (preferably resisting up toabout 4 atm) in the inner catheter 212.

[0116] In FIG. 35, the tubing component 216 is inflated via anadditional lumen 242 which extends from the proximal end of the catheteralong the guide wire lumen 240, much the same as any inflating lumenincorporated to inflate a balloon.

[0117] In an alternative embodiment, as shown in FIG. 36, socks orsleeves 251 may be incorporated to stretch over the ends of the stent toprevent snagging and to secure the stent onto the balloon. Such sleevesare demonstrated in U.S. application Ser. Nos. 08/702,149, filed Aug.23, 1996, and 08/701,979, filed Aug. 23, 1996, which are incorporated intheir entirety herein by reference.

[0118] In still another embodiment, as shown in FIG. 37, the tubingcomponent 216 is slidable axially along the inner shaft 212 and isconnected to a retracting wire 250 such that the tubing component may beretracted into the outer shaft 213 after the balloon has been inflatedto reduce the profile of the balloon 214 when the catheter is removed.The tubing component, since it is not adhered to the inner shaft 212 inthis embodiment, should fit tightly enough on the inner shaft to stay inplace, but not too tightly so that it may be retracted by pulling on theretracting wire 250.

[0119] The method of using the stent delivery and deployment assembly210 of this invention, as shown in FIGS. 1 and 2, is described asfollows. The assembly 210 is constructed as described above. Stent 218is compressed or crimped onto balloon 214, tube component 216 and thecatheter to a delivery diameter D1. This crimping can be done manuallyor with the aid of tooling specifically designed for the purpose eitherby the physician or the manufacturer. In the crimped position, stent 218closely conforms to the overall profile of balloon 214, tube component216 and the catheter except for the slight slack or looseness due torecoil crimping. Tube component 216 is flexible enough to slightlycollapse during crimping and rebound to the extent necessary tocompensate for the slack or looseness due to recoil crimping, thussecuring the stent. As a result, the stent does not move out of itsposition on the catheter during delivery or become separated from thecatheter within a body vessel. The catheter distal end is delivered bystandard techniques to the deployment site within the body vessel ofinterest. At this point, stent 218 is positioned as required by thephysician and balloon 214 is fluid inflated by standard technique toexpand stent 218 to its deployment diameter D2. During this expansion,stent 218 is expanded to fill the body vessel. Following deployment ofstent 218, balloon 214 is deflated and the assembly is retractedproximally and withdrawn from the body. If required by the procedure,the site of entry to the body is appropriately closed.

[0120] The tube component provided by this invention increases stentsecurement force by increasing the frictional force between the tubecomponent, the balloon wall and the internal diameter of the stent inits reduced crimped delivery diameter. The tube component is moreflexible than a solid sheath under the expandable balloon, and thus theentire assembly has greater flexibility. This invention has particularadvantages for assemblies in which the stent is provided for use aspre-crimped to the balloon and underlying catheter, by increasing theshelf life of the pre-crimped assembly. The tube component also protectsthe balloon material during crimping by acting as a buffer between theballoon material and whatever may be mounted on the inner shaft, such asmarker bands 217. The features and principles described for thisinvention are suitable for use with fixed wire, over-the-wire and singleoperator exchange assemblies.

[0121] FIGS. 38-46 disclose alternative embodiments of the securementdevice. FIG. 38 shows a stent delivery and deployment assembly generallydesignated 310. A catheter 312 has a collar 314 coaxially mounted at thecatheter distal end portion 316. An uninflated balloon 318 is coaxiallymounted on catheter 312 over collar 314. An unexpanded stent 320 iscoaxially mounted on the balloon 318 abutting but not overlying collar314. A cup 322 coaxially overlies the stent proximal end portion 324.Cup 322 may be elastomeric or rigid, preferably elastomeric. Cup 322 isover-expanded over the stent 320, so that recoil of the cup 322 issufficient to secure stent 320 in place and prevent it from being pulledoff of the assembly 310 distally or proximally as assembly 310 isdelivered to a deployment site in a body vessel. Cup 322 also protectsthe proximal end of stent 324 from inadvertently catching on anatomicalstructures or other things during maneuvering within the body or duringloading and other handling. The ends of the stent may axially protrudeand should be protected during maneuvering of stent 320 to keep stent 20on assembly 310 in its contracted configuration and to maintain thestructural integrity of stent 320. Collar 314 abuts the stent distal end326 without underlying stent 320. The position of cup 322 overlyingstent 320 and containing stent 320 against collar 314 increases thesecurement force maintaining stent 320 in its axial and radial positionon catheter 12. FIG. 40 is similar to FIG. 38, showing a bulge 28beneath the uninflated balloon 318 at catheter distal end 316.

[0122] Any of the various types of known stents may be used in thedelivery system of this invention, even self-expanding stents which arepartly balloon-expandable may be used, the balloon initiating release ofthe stent and/or finally seating the stent after self-expansion.However, ordinary balloon expandable stents are preferred andaforenoted.

[0123]FIG. 39 shows another stent delivery and deployment assemblygenerally designated 330. A catheter 332 has a collar coaxially mountedas a mounting ring 334 on the catheter. An uninflated balloon 338 iscoaxially mounted on catheter 332 over mounting ring 334. An unexpandedstent 340 is coaxially mounted on balloon 338 overlying the mountingring 34. A cup 342 overlies the stent proximal end portion 344 to securethe stent 340 in place and prevent it from being pulled off of assembly330 distally or proximally, as assembly 330 is delivered to a deploymentsite in a body vessel. Cup 342 also protects the proximal end of stent40 from inadvertently catching on anatomical structures duringmaneuvering within the body. The position of cup 342 overlying stent 340together with the closer positioning of mounting ring 334 as compared toFIG. 38 increases the securement force maintaining stent 340 in itsaxial and radial position on catheter 342. The closer the mounting ring334 is positioned to cup 342 the more securely the stent is held inplace and interlocked between this cup and ring. When used inconjunction with mounting ring 334, cup 342 will also prevent the stentproximal segment 344 from opening up, i.e., increasing its diameter, andwill keep the stent 340 locked onto the mounting ring 334. This willprevent stent 340 from moving on the catheter distally as well asproximally. This cup does not have to be an elastomer, but may besufficiently rigid to prevent the stent 340 from expanding.

[0124] Cups 322, 342 of FIGS. 38-40 release stents 320, 340 whenballoons 318, 338 are inflated during deployment. Cups 322, 342 can, forexample, flare radially outward as illustrated with reference to FIG.41, roll axially away from stents 320, 340 as illustrated with referenceto FIG. 42, or slide axially away from stents 320, 340 as illustratedwith reference to FIGS. 43 and 44. Also, the cups may be formed withaxial areas of weakness which split on balloon inflation, as describedin the aforenoted Savin patent.

[0125]FIG. 41 shows an assembly generally designated 310 as shown inFIGS. 38 and 36 with balloon 318 inflated and stent 320 expanded,showing the cup 322 end portion flared to release stent 320. As notedabove, cup 322 may be elastomeric or rigid. The dimension L is shortenough and the material of cup 322 is sufficiently elastic so that cup322 flares out and is no longer in contact with stent 320 when balloon318 is inflated and the stent 320 expanded for deployment.

[0126]FIG. 42 shows an assembly generally designated 310, as shown inFIGS. 38 and 36, with balloon 318 inflated and stent 320 expanded,showing cup 322 end portion rolled proximally to release the stent 320.As noted above, the cup 322 may be elastomeric to facilitate rolling.The cup may also accordion or bunch up on itself to release the stent.

[0127]FIGS. 43 and 44 show yet another stent delivery and deploymentassembly generally designated 350. The catheter 352 has a coaxial collar354 formed integrally with catheter 352 at the catheter distal end 356.A balloon 358 is coaxially mounted on catheter 352, overlying collar354. In FIG. 43, balloon 358 is coaxially mounted on catheter 352,overlying collar 354. In FIG. 43, balloon 358 is shown as uninflated,with an unexpanded stent 360 mounted on balloon 358 abutting collar 354,and a cylindrical cup in the form of sleeve 362 overlying the stentproximal end portion 364. FIG. 44 shows the assembly 350 of FIG. 43 withballoon 358 inflated and stent 360 released and expanded. Sleeve 362 isdesigned, constructed and adapted so that, as balloon 358 and stent 360are enlarged, the sleeve portion 366 gathers or moves proximally torelease stent 360. The increasing angle of the balloon 358 cone (thetapered end sections of balloon 358) during inflation push sleeve 362axially away from stent 360. This can be done by shaping sleeve 362 withpreformed accordion pleats 368. Sleeve 362 may also be formed so thatthe portion detaining (that is, abutting or overlying) stent 360 is ofthicker or more rigid material than the portion of sleeve 362 axiallydistant from stent 360. Materials which may be used to provide theforegoing function are silicones, urethanes and the like as well asother elastomers, for example. A rigid sleeve carried on the catheterfor sliding movement may also be used. Sleeves may be included at theproximal and distal end of the stent.

[0128]FIG. 45 shows still another stent delivery and deployment assemblygenerally designated 370. A catheter 372 has two collars 374 formedintegrally with catheter 372 and spaced from each other on the catheterdistal end portion. A balloon 378 is coaxially mounted on the catheter372, overlying the collars 374. The balloon 378 is shown as uninflatedwith an unexpanded stent 380 mounted on balloon 378 abutting both of thecollars 374. It can be seen that the distance between the collars 374 isto be chosen to closely accommodate stent 380 in its fully contractedposition about the balloon 378 and underlying catheter 372. A cup 382overlies the stent proximal end portion 384 and the underlying proximalcollar 374. Cup 382 will deploy during balloon 378 inflation in themanner described above with reference to FIGS. 41-44.

[0129]FIG. 46 shows even another stent delivery and deployment assemblygenerally designated 390. The uninflated balloon 398 is shown coaxiallymounted on a catheter 392 at the catheter distal end portion. Anunexpanded stent 400 is coaxially mounted on balloon 398. A pair of cups402 overlap the ends of the stent 400 ends. A mounting cylinder 404 iscarried by the catheter shaft 392.

[0130] The Figure also illustrates cups at both ends of the stent, anarrangement which may be used in all the foregoing embodiments.

[0131] The cups or sleeves used in the various embodiments of thisinvention can be of elastomeric or rigid material to contain one or bothends of the stent. In preferred embodiments of this invention the cupsare used in conjunction with one or more stent collars positioned underthe balloon. The collar may be formed as a ring, to abut the end of thestent, to lie under the stent and the intervening balloon, or as acylinder, to lie under essentially the entire length of the stent andthe intervening balloon. The stent detainment according to the presentinvention offers increased stent securement, particularly on pre-mounteddelivery systems. The cups and sleeves illustrated in the variousembodiments of this invention can be secured to the catheter, as byadhesive or thermal bonding, or they may be sliding cups or sleeves.When the cups are freely sliding on the catheter, they should always beused directly over a collar so that there is a friction fit between thecup and the stent.

[0132] A method for delivering and deploying a stent using an assemblyaccording to the present invention is described as follows: A catheteris provided as described above with reference to any of FIGS. 38-40, 43and 45. At least one collar is coaxially mounted at the catheter distalend. As discussed above, the collar may be a separate element affixed tothe catheter or the collar and catheter may be formed together as asingle element. The collar may be positioned abutting an end of thestent. The collar may be a mounting ring, may be positioned under thestent or underlying the balloon. The collar may be a cylinderessentially coextensive in length with the stent and underlying theballoon. A fluid expandable balloon is coaxially mounted over the collaron the catheter distal end. A stent is provided which is inflationexpandable from a reduced to an enlarged condition. The stent, in itsreduced condition, is coaxially mounted on the balloon so that at leastan end portion of the stent overlies the balloon. A cup is providedwhich has first and second end portions. The cup is in an expanded formand also has a retracted form. The expanded cup is coaxially mounted onthe catheter at the distal end portion so that the cup first end portiondetains the stent end portion. The cup first end portion detains thestent end portion by overlying the stent end portion, or by closelyaccommodating the stent against the collar without overlying the stentend portion. The cup is then contracted about the catheter and the stentend portion to fix the stent to the catheter. The cup and collarcooperate to retain the stent on the catheter in its reduced condition.The assembly is then maneuvered by the physician through a body vesselby methods known per se to reach a pre-selected deployment site. Thesurgeon can determine when the assembly has reached the deployment siteby means which are themselves known per se. For example, the assemblymay be provided with radiopaque marking bands at either end of thestent, or the cups or the collars or both may be made of radiopaquematerial. Once the surgeon determines that the stent has been correctlypositioned at the desired site, the balloon is inflated to expand thestent to its enlarged condition. Inflation of the balloon expands thestent and the stent is released from the cup or cups. As has beendiscussed above, the cups may deploy to release the stent in a number ofways, dependant on the construction and materials of the cup or cups.The cup may flare or enlarge radially following the increasing angle ofthe balloon cones. The cup may roll axially away from the stent. Theportion of the cup axially distant from the stent may accordion back onitself. The cup may slide axially. The cup may accordion or buckle. Ifthe cup is not fixed to the catheter, but is freely slidable on thecatheter, the cup may slide axially away from the stent. Afterdeployment of the stent, the balloon, according to previously knownprocedures, is deflated and the assembly is withdrawn proximally fromthe body vessel. Any incision made to allow access from the assembly isappropriately closed.

[0133] FIGS. 47-56 illustrated alternative embodiments of securementdevices. Referring to FIGS. 47 and 48 a stent delivery system generallyindicated at 410 includes a balloon catheter 412 having a balloon 414 ona distal end portion generally indicated at 416. FIG. 47 shows aproximal portion of the catheter at 412 a and a distal portion 412 b inenlarged view. FIG. 48 shows the distal end portion 416 in an even moreenlarged view. The illustrative catheter 412 is of the type known as anover the wire catheter. However, other types of catheters may be used,such as rapid exchange/single operator exchange and fixed wire types.The balloon 414 is fixed to the catheter 412 by standard means. Theballoon is shown in its contracted state in FIGS. 47 and 48. A stent 418is fixed about the balloon by crimping it thereto. The stent has alarger expanded diameter which is obtained when the balloon is expandedin the known manner. That is, the stent is released from the catheterupon expansion of the balloon when placed in a vessel. When the balloonis then deflated, removal of the balloon and catheter may beaccomplished while leaving the stent in place.

[0134] As is known in the art the balloon is either bonded at its endsby adhesive 420 and 422, respectively to the outer member 424 of thecatheter and to the inner member 426 of the catheter in the manner asshown, or is made one-piece with the outer member as is known in theart. The catheter balloon may be inflated by fluid (gas or liquid) froman inflation port extending from a lumen 428 contained in the cathetershaft and opening into the balloon as shown, or by other knownarrangements, depending on the design of the catheter. The details andmechanics of balloon inflation and specific overall catheterconstruction will vary according to the particular design involved inany given instance, and are known in the art per se. All variations areacceptable for use with this invention.

[0135] Any balloon expandable stent may be used with this invention.Many are known in the art including plastic and metal stents. Some aremore well known such as the stainless steel stent shown in U.S. Pat. No.4,735,665; the wire stent shown in U.S. Pat. No. 4,950,227; anothermetal stent shown in European Patent Application No. EPO 707 837 A1 andthat shown in U.S. Pat. No. 5,445,646. All of these patents areincorporated herein by reference. Also, shape memory metal stents may beused. As already indicated the stent of PCT Application 960 3092 A1 isparticularly preferred.

[0136] The stent is typically about 16 mm long, while the balloon may be20 mm long. These dimensions, however, are merely representative forillustrative purposes only and are not meant to be limiting. The stentis positioned over the balloon portion of the dilatation catheter andgently crimped onto the balloon either by hand or with a tool such as apliers or the like to be mounted for delivery as shown in FIGS. 47 and48. The crimping may be accomplished by either the manufacturer or thephysician.

[0137] In accordance with one embodiment of this invention, a mountingbodies 430, seen in FIGS. 47 and 48 are included inside balloon 414 toprovide a cushion and/or substrate of enlarged diameter relative to theshaft to support and hold the stent and secure it during crimping andthe delivery procedure. The mounting bodies are preferably located inthe body portion of the balloon.

[0138] In the embodiment shown, mounting bodies 430 are ring-like inform and are mounted on inner lumen 426, providing an enlarged area orportion for receiving the balloon and stent when the latter is crimped.Marker bands 432 and 434 may also be included on inner 426 as shown. Anyradiopaque material such as gold is useful for this purpose. Although,the material of the mounting bodies may be hard, it is preferably of anythermoplastic elastomer having elastic or deformable properties, morepreferably of a relatively resilient elastomer material, e.g., silicone,preferably a lower durometer silicone, or polyurethane, such asTecothane 1055D. A deformable thermoplastic material such as highdensity polyethylene (HDPF) may be used. Any deformation of resilientmaterial of the mounting body when the stent/balloon is crimped to itcauses a radial outward force on the stent/balloon increasing thefriction therebetween despite a recoil of the stent.

[0139] The stent is also fixed in position by two overlying retainingsleeves 436 and 438. Sleeves 436 and 438 are formed of polyurethane,preferably Tecothane 1055D, and are axially fixed on catheter 412 byadhesive plugs 440 and 442 of urethane adhesive. The plugs of adhesivemay be tapered to the catheter as shown to facilitate movement of thecatheter in a vessel. The sleeves overlap the marginal end portions ofstent 418 as shown.

[0140] A lubricating solution such as silicone fluid may be used betweenballoon 414 and sleeves 436 and 438 and thereon to facilitate release ofstent 418 from the sleeves.

[0141] During delivery, the balloon catheter is advanced through andpositioned in a patient's vasculature so that the stent is adjacent tothe portion of the vessel where treatment is to take place. The balloonis inflated to expand the stent to an enlarged diameter. At this time,expansion of the balloon causes the end margin of the sleeves to slideaxially from over the stent thereby releasing the ends of the stent fromthe catheter. Various forms of retraction of sleeves 436 and 438 areshown in FIGS. 49-52. These figures illustrate the configuration of thesleeves 436 and 438 in their retracted state after the balloon 414 hasbeen fully expanded. Only the distal sleeve 438 is shown. FIG. 49illustrates the preferably retraction configuration. To promote easierretraction sleeves are coated with silicone. The sleeves are preferablyadhered to the outer shaft 424 and the inner shaft 426 at point 440,442, but may be adhered further up the waste 441 of the balloon. Theretraction configurations may be controlled by either pre-creasing thesleeves or adhering the sleeve to a point further up on the waist of theballoon. The sleeves have a tendency of folding at a pre-fold crease orat the point of adherence. A preferred cone angle of 45° for the balloonis shown in FIG. 52, which shows an expanded balloon 414 and retractedsleeves 436,438. When the stent has reached the desired diameter, theballoon is deflated so that the catheter may be removed leaving thestent in place.

[0142] A modified 439 sleeve configuration is shown in FIG. 53 instepped form 43 having a large diameter at 444 in one section 446 and asmall diameter 445 in a second section 450.

[0143] FIGS. 54-56 show alternative embodiments of the invention.Specifically, alternative positioning and number of mounting bodies 430.These figures show an unexpanded balloon having the mounted bodies 430within the balloon. They are meant to illustrate essentially the samestructure as shown in FIG. 448 differing only in the number andpositioning of the mounted bodies 430. In the embodiment shown in FIG.54, the ring-like mounting body 430 is singular. Another similar versionis shown in FIG. 55 which includes three ring-like mounting bodies 430.The embodiment shown in FIG. 56 includes four ring-like mounting bodies430.

[0144] It should be understood that the various elements and materialsof all embodiments could be utilized in each of the other embodiments,if desired.

[0145] The above Examples and disclosure are intended to be illustrativeand not exhaustive. These examples and description will suggest manyvariations and alternatives to one of ordinary skill in this art. Allthese alternatives and variations are intended to be included within thescope of the attached claims. Those familiar with the art may recognizeother equivalents to the specific embodiments described herein whichequivalents are also intended to be encompassed by the claims attachedhereto.

What is claimed is:
 1. A system/assembly for delivery and deployment ofan inflation expandable stent within a vessel, comprising: a catheterhaving proximal and distal ends; a stent, inflation expandable from adelivery diameter to a deployment diameter, such that the deliverydiameter is reduced from the deployment diameter for conforming thestent to the catheter, such that the stent, in its delivery diameter, iscoaxially mounted on the catheter near the catheter distal end; anexpandable inflation means coaxially mounted on the catheter axiallywithin the stent, for expansion of the stent from the delivery diameterto the deployment diameter upon application of fluid deployment pressureto the inflation means; and a securement component coaxially mounted onthe catheter, axially within the expandable inflation means, thesecurement component designed and adapted to provide a securementpressure to the stent in the delivery diameter to maintain the stent inposition on the catheter during delivery to the deployment site.
 2. Thesystem of claim 1 , the catheter having a shaft and the expandableinflatable means associated therewith at a distal part of the shaft andincluding mounting and retaining means for receiving the stent on theexpandable means for radial expansion of the stent, the mounting andretaining means being associated with the inflatable means and beingconstructed and arranged for selectively providing an enlarged mountingbody for receiving the stent.
 3. The system of claim 2 wherein themounting body is inside the inflatable means.
 4. The system of claim 2wherein the mounting body is outside the inflatable means.
 5. The systemof claim 2 , the inflatable means being a balloon, wherein the mountingbody is carried by the catheter and is axially movable between the stentmounting position associated with the balloon and a position removedfrom the stent mounting position.
 6. The system of claim 1 , thecatheter having a shaft, the expandable inflatable means beingassociated therewith at a distal part of the shaft and includingmounting and retaining means for receiving a stent on the expandableinflatable means and for radial expansion of the stent upon inflation ofthe inflatable means, the mounting and retaining means including atleast one mounting body carried on and surrounding the shaft inside theinflatable means whereby the diameter of the shaft and inflatableportion may be increased at the distal part of the shaft forfacilitating the mounting and retaining of the stent.
 7. The deliverysystem of claim 6 wherein the mounting body is axially movable withrespect to the inside shaft, and including means for moving the mountingbody.
 8. The stent delivery system of claim 7 wherein the mounting bodyis of a material which resiliently deforms under radial pressure.
 9. Thestent delivery system of claim 8 wherein the material comprises HDPE orsilicone.
 10. The stent delivery system of claim 7 wherein the mountingbody configuration includes at least one separation whereby theflexibility of the body and catheter is increased.
 11. The stentdelivery system of claim 1 0 wherein the separation is in the form of aspiral.
 12. The stent delivery system of claim 7 wherein the mountingbody is positionable to receive a stent and a stent is crimped to themounting and retaining means over the balloon for delivery.
 13. Thestent delivery system of claim 6 including a stop positioned at thedistal end portion of the inflatable means and carried by the shaftinside the inflatable means.
 14. The stent delivery system of claim 6including at least one marker band.
 15. The stent delivery system ofclaim 6 wherein the inflatable means comprises a balloon.
 16. The stentdelivery system of claim 6 including a stop positioned at the distal endof the catheter and carried by the shaft inside the inflatable means.17. The stent delivery system of claim 6 wherein the mounting body is ina fixed position and is adapted and arranged to enlarge in diameter toreceive a stent.
 18. The stent delivery system of claim 17 wherein themounting body is a second inflatable means inside the first inflatablemeans, the inner one being shaped to have wide end portions and a narrowcenter portion.
 19. The stent delivery system of claim 17 wherein themounting body is a coil-like structure adapted and arranged to becompressed and the proximal portion of the inside shaft is connectedthereto for compressing the structure to enlarge its diameter.
 20. Thesystem of claim 17 wherein the mounting body is a sleeve includingradial accordion like pleats extending over at least a portion of itslength, the distal end being secured to the inside shaft and a means forcompressing the body from its proximal end and attached thereto.
 21. Thesystem of claim 20 wherein the pleats of certain portions of the bodyare spaced differently to provide regions of different enlargement. 22.The stent delivery system of claim 19 wherein the coil is coated with apolymer.
 23. The stent delivery system of claim 29 wherein the coil isenclosed in a polymeric sheath.
 24. The stent delivery system of claim 7wherein the mounting body is a slidably carried coil.
 25. The system ofclaim 1 , the inflation means being a balloon, and further including anelastomeric sheath carried over the balloon, the sheath beingconstructed and arranged for axial movement and positioning between astent mounting position over the balloon and a position removed from thestent mounting position.
 26. A method of changing the profile of aballoon catheter for improving the mounting of a stent thereon andproviding a catheter for multiple use, comprising the steps of:providing a balloon catheter of relatively low profile adapted andrearranged for use in an angioplasty procedure; sliding a stent mountingbody to a position associated with the balloon to a position forreceiving a stent and enlarging the catheter profile at that position,and mounting a stent on the balloon and mounting body at that position.27. In a balloon catheter apparatus, the method of enlarging thecatheter profile for facilitating the mounting of a stent thereon,comprising: selectively providing an enlarged mounting body within theballoon in a position to receive a stent.
 28. The method of claim 27wherein the enlarged body is provided by sliding it into the position.29. The method of claim 27 wherein the enlarged body is provided byinflating an inner balloon within the catheter balloon.
 30. The methodof claim 27 wherein the enlarged body is provided by compressing a bodyalready in the position to enlarge its diameter for receiving a stent.31. The assembly of claim, the inflatable means being an expandableballoon coaxially mounted on the catheter axially within the stent, forexpansion of the stent from the delivery diameter to the deploymentdiameter upon application of fluid deployment pressure to the balloon;and the securement component being an expandable tube componentcoaxially mounted on the catheter, axially within the expandableballoon, the tube component designed and adapted for fluid expansion toprovide a securement pressure to the stent in the delivery diameter tomaintain the stent in position on the catheter during delivery to thedeployment site.
 32. The assembly according to claim 31 , wherein theexpandable tube component is sized and constructed to be fluidexpandable to no more than the delivery diameter and to no more than thesecurement pressure.
 33. The assembly according to claim 31 , whereinthe tube component is essentially equal in length to the stent andwherein the stent is positioned on the assembly essentially coextensivewith the tube component.
 34. The assembly according to claim 32 ,wherein the tube component is comprised of more than one inflatablepouch.
 35. The assembly according to claim 34 , wherein the tubecomponent is comprised of three pouches, with a proximal and distalpouch inflatable to a greater pressure than a medial pouch.
 36. A methodfor delivering and deploying a stent using an assembly according toclaim 3 1, comprising: providing a catheter having proximal and distalends, with an expandable balloon coaxially mounted on the catheter, andan expandable tube component coaxially mounted on the catheter, axiallywithin the expandable balloon, so that the balloon and the tubecomponent are each in an unexpanded condition; providing a stent whichis expandable from a delivery diameter to a deployment diameter;mounting the stent, in a diameter greater than the delivery diameter, onthe balloon; contracting the stent to the delivery diameter to conformto an overall profile of the catheter, the tube component and theballoon; inflating the tube component to provide to the stent asecurement pressure to retain the stent in the delivery diameter;delivering the assembly to a deployment site; and inflating the balloonto expand the stent to its deployment diameter.
 37. The method accordingto claim 36 , wherein the expandable tube component is sized andconstructed to be fluid expandable to no more than the deliverydiameter.
 38. The method according to claim 36 , wherein the tubecomponent is essentially equal in length to the stent and wherein thestent is positioned on the assembly essentially coextensive with thetube component.
 39. The method according to claim 36 , wherein the tubecomponent is comprised of more than one inflatable pouch.
 40. The methodaccording to claim 39 , wherein the tube component is comprised of threepouches, with a proximal and distal pouch inflatable to a greaterpressure than a medial pouch.
 41. The assembly according to claim 1 ,the catheter having an inner shaft, the inflatable means being anexpandable balloon coaxially mounted on the catheter axially; and thesecurement component comprising a tube component coaxially mounted onthe catheter axially within the expandable balloon, the tube componenthaving a plurality of ribs.
 42. The assembly according to claim 41 ,further comprising a stent, inflation expandable from a deliverydiameter to a deployment diameter, such that the delivery diameter isreduced Prom the deployment diameter for conforming the stent to thecatheter, such that the stent, in its delivery diameter, is coaxiallymounted on the catheter near the catheter distal end, the expandableballoon being capable of expansion of the stent from the deliverydiameter to the deployment diameter upon application of fluid deploymentpressure to the balloon.
 43. The assembly according to claim 42 , thecatheter comprising an inner shaft and an outer shaft, wherein the tubecomponent is a thermoplastic corrugated tube adhered to the inner shaftand is formed from a low modulus polymer.
 44. The assembly according toclaim 43 , the tube component being formed from a material chosen fromthe group consisting of polypropylene, low density polyethylene (LDPE),high density polyethylene (HDPE), ethylene vinyl acetate (EVA), nylon,polyester, polyethylene terephthalate (“PET”), Surlyn™, Pebax andurethane.
 45. The assembly according to claim 43 , wherein the diameterof the tube component is approximately equal to the delivery diameter ofthe stent.
 46. The assembly according to claim 45 , wherein the tubecomponent is essentially equal in length to the stent and wherein thestent is positioned on the assembly essentially coextensive with thetube component.
 47. The assembly according to claim 42 , wherein thetube component is comprised of more than one corrugated tube.
 48. Theassembly according to claim 46 , further comprising marker bands fixedto the inner shaft beneath the tube component.
 49. The assemblyaccording to claim 42 , wherein the tube component is inflatable, suchthat when the tube component is inflated it applies radial pressure onthe expandable balloon, when the stent is in its delivery diameter. 50.The assembly according to claim 42 , further comprising at least onesleeve having first and second ends, the first end being attached to thecatheter and the second end covering a portion of the stent, when thestent is in its delivery diameter.
 51. The assembly according to claim50 , comprising two sleeves, one covering each end of the stent, whenthe stent is in its delivery diameter.
 52. The assembly according toclaim 42 , wherein the tube component is slidable along the inner shaftand is attached to a retracting means, such that after the stent hasbeen deployed, the user may slide the tube component proximally alongthe inner shaft.
 53. A method for delivering and deploying a stent usingan assembly according to claim 41 , comprising: providing a catheterhaving proximal and distal ends, with an expandable balloon coaxiallymounted on the catheter, and a tube component having a plurality of ribscoaxially mounted on the catheter, axially within the expandableballoon, so that the balloon is in an unexpanded condition; providing astent which is expandable from a delivery diameter to a deploymentdiameter; mounting the stent, in a diameter greater than the deliverydiameter, on the balloon; contracting the stent to the delivery diameterto conform to an overall profile of the catheter, the tube component andthe balloon; delivering the assembly to a deployment site; and inflatingthe balloon to expand the stent to its deployment diameter.
 54. Themethod according to claim 53 , wherein the tube component is a corrugatetubing adhered to the catheter formed of a low modulus polymer andhaving a diameter of approximately that of the delivery diameter. 55.The assembly of claim 1 , the inflatable means comprising an expandableballoon, further comprising an annular collar coaxially located at thecatheter distal end portion, the expandable balloon coaxially mountedover the collar at the catheter distal end portion, the balloon beingexpandable from a contracted to an expanded state, the stent coaxiallymounted on the balloon, the reduced condition conforming the stent tothe balloon, collar and catheter, the stent having at least an endportion overlying the balloon, the system further comprising a cupcoaxially mounted on the catheter distal end portion, the cup having afirst end portion restraining the stent end portion and the cup andcollar cooperatively constructed and arranged to retain the stent endportion on the catheter in the stent reduced condition when the balloonis in the contracted state, the balloon and catheter cooperativelyconstructed and arranged to cause expansion of the balloon from thecontracted to the expanded state and to release the stent end portionfrom the cup end portion.
 56. The assembly according to claim 55 ,wherein the cup is axially spaced from the collar.
 57. The assemblyaccording to claim 55 , wherein the cup has a second end portion fixedto the catheter.
 58. The assembly according to claim 55 , wherein thecup first end portion overlies the stent end portion.
 59. The assemblyaccording to claim 55 , wherein the cup is elastomeric.
 60. The assemblyaccording to claim 55 , wherein the cup is rigid.
 61. The assemblyaccording to claim 57 , wherein the second end portion is fixed withadhesive.
 62. The assembly according to claim 55 , wherein the collar isformed as a single member with the catheter.
 63. The assembly accordingto claim 55 , wherein the stent end portion is a distal end portion andwherein the cup and collar cooperate to retain the stent at the stentdistal end portion.
 64. The assembly according to claim 55 , wherein thecollar is axially positioned exterior to the stent at a stent endportion opposite the stent end portion retained by the cup.
 65. Theassembly according to claim 64 wherein the collar is formed as a singlemember with the catheter.
 66. The assembly according to claim 55 ,wherein the collar is a mounting ring axially positioned between stentend portions.
 67. The assembly according to claim 66 , wherein themounting ring is formed as a single member with the catheter.
 68. Theassembly according to claim 66 , wherein at least a portion of themounting ring is contained by the cup.
 69. The assembly according toclaim 55 , wherein the collar is a cylinder under the stent.
 70. Theassembly according to claim 69 , wherein at least a portion of thecylinder is contained by the cup.
 71. The assembly according to claim 69, wherein the cylinder is formed as a single member with the catheter.72. The assembly according to claim 55 , wherein a second collar is amounting ring axially positioned between stent end portions.
 73. Theassembly according to claim 55 , wherein a second collar is axiallypositioned immediately exterior to the stent at a stent end portionopposite the stent end portion retained by the cup.
 74. The assemblyaccording to claim 55 , wherein the cup and the collar are eachcylindrical.
 75. The assembly according to claim 55 , wherein the cuphas a second end portion with axially running regions of weakness. 76.The assembly according to claim 55 , and further including a second cupcoaxially mounted on the catheter at the catheter distal end, the secondcup having a first end portion overlying a stent second end portion; thecups and the collar cooperatively constructed and arranged to retain therespective stent end portions on the catheter in the stent reducedcondition when the balloon is in the contracted state, the balloon andcatheter cooperatively constructed and arranged to cause expansion ofthe balloon from the contracted to the expanded state to cause releaseof the stent end portions from the cup end portions.
 77. The assemblyaccording to claim 76 , wherein the cups are elastomeric.
 78. Theassembly according to claim 76 , wherein the cups are rigid.
 79. Theassembly according to claim 76 , wherein the collar is formed as asingle member with the catheter.
 80. The assembly according to claim 76, wherein the collar is axially positioned immediately exterior to thestent at a stent end portion opposite the stent end portion retained bythe cup.
 81. The assembly according to claim 80 , wherein the collar isshaped as a single member with the catheter.
 82. The assembly accordingto claim 76 , wherein the collar is a mounting ring axially positionedbetween stent end portions.
 83. The assembly according to claim 82 ,wherein the mounting ring is shaped as a single member with thecatheter.
 84. The assembly according to claim 82 , wherein at least aportion of the mounting ring is contained by a cup.
 85. The assemblyaccording to claim 76 , wherein the collar is a cylinder coextensivewith the length of the stent.
 86. The assembly according to claim 85 ,wherein the cylinder is formed as a single member with the catheter. 87.The assembly according to claim 85 , wherein at least a portion of thecylinder is contained by a cup.
 88. The assembly according to claim 87 ,wherein each cup contains at least a portion of the cylinder.
 89. Theassembly according to claim 76 , wherein a second collar is a mountingring axially positioned between stent end portions.
 90. The assemblyaccording to claim 76 , wherein a second collar is axially positionedimmediately exterior to the stent at a stent end portion opposite thestent end portion retained by the cup.
 91. The assembly according toclaim 76 , and further comprising fixing means for holding the collar ata specific location on the catheter, wherein the fixing means isadhesive.
 92. A method for delivering and deploying a stent using theassembly of claim 55 , comprising: providing a catheter having proximaland distal ends, with a collar coaxially mounted at the catheter distalend, and a fluid expandable balloon coaxially mounted over the collar onthe catheter distal end, providing a stent being expandable from areduced to an enlarged condition; mounting the stent in the reducedcondition coaxially on the balloon, so that an end portion of the stentoverlies the balloon; providing a cup having first and second endportions, the cup being in an expanded form, and also having a retractedform; mounting the expanded cup coaxially on the catheter distal end, sothat the cup first end portion overlies the stent end portion;contracting the cup about the catheter and the stent end portion to fixthe stent to the catheter, the cup and collar cooperating to retain thestent in the reduced condition, delivering the assembly to a deploymentsite; and inflating the balloon to release the stent from the cup. 93.The assembly according to claim 1 , the securement component comprisinga mounting body carried by the catheter at the distal end portion, theinflatable means comprising an expandable balloon coaxially mounted overthe catheter distal end and the mounting body, the balloon beingexpandable from a contracted to an expanded state, the stent having anend portion overlying the balloon, the assembly comprising: first andsecond cups coaxially mounted on the catheter distal end, each cuphaving a first end portion overlying a stent end portion, respectively;and the cups constructed and arranged to retain the stent therebetweenon the catheter in the stent reduced condition when the balloon is inthe contracted state, the balloon and catheter cooperatively constructedand arranged to cause expansion of the balloon from the contracted tothe expanded state to cause expansion of the stent, including the stentend portions, from the reduced to the enlarged condition, and therebyrelease the stent from abutting the cup end portions.
 94. A method fordelivering and deploying a stent using the assembly of claim 93 ,comprising: providing a catheter having proximal and distal ends and afluid expandable balloon coaxially mounted over the collar on thecatheter distal end; providing a stent being inflation expandable from areduced to an enlarged condition; mounting the stent in the reducedcondition coaxially on the balloon so that an end portion of the stentoverlies the balloon; providing first and second cups each having firstand second end portions, the cups being in an expanded form and alsohaving a retracted form; mounting the expanded cups coaxially on thecatheter distal end so that the cup first end portions overlie the stentend portions; contracting the cups about the catheter and the stent endportions to fix the stent to the catheter, the cups cooperating toretain the stent in the reduced condition; delivering the assembly to adeployment site; and inflating the balloon to expand the stent to itsenlarged condition, whereby the stent is released from the cups.
 95. Thesystem according to claim 1 , the catheter having a shaft and theinflatable/expandable means being associated therewith at a distal partof the shaft, the securement component comprising mounting and retainingmeans for receiving the stent on the expandable means for radialexpansion of the stent upon expansion of the expandable means, themounting and retaining means including at least one mounting bodycarried on the shaft inside the inflatable means whereby the diameter ofthe shaft and expandable means are increased at the distal part forfacilitating the mounting and retaining of the stent, and furtherincluding a sleeve at the distal portion of the catheter, having a firstend fixed to the catheter and a second end overlying an end portion ofthe stent, the sleeve sliding axially to release the stent uponexpansion of the expandable means.
 96. The stent delivery system ofclaim 95 wherein the mounting body is of a material which resilientlydeforms under radial pressure.
 97. The stent delivery system of claim 96wherein the material is elastomeric.
 98. The stent delivery system ofclaim 96 wherein the material comprises polyurethane.
 99. The stentdelivery system of claim 95 wherein the stent is crimped to the mountingand retaining means for delivery.
 100. The stent delivery system ofclaim 95 including marker bands positioned on the shaft proximally anddistally of the stent.
 101. The stent delivery system of claim 95wherein the expandable means comprises a balloon.
 102. The stentdelivery system of claim I, the catheter having a shaft and theinflatable/expandable means associated therewith at a distal part of theshaft, the securement component including mounting and retaining meansfor receiving the stent to be delivered upon expansion of the inflatablemeans, the mounting and retaining means including at least one ring-likebody inside the expandable means and carried by the shaft, and the stentcrimped to the expandable means and the mounting body such that thestent is carried on the shaft and mounting body until expansion of thestent and expandable means, the system further comprising a first andsecond sleeve in the distal part of the catheter positioned around thecatheter, each having a first end fixed to the catheter and a second endoverlying first and second end portions of the stent respectively, thefirst and second sleeves separately fixing the stent before expansionthereof and upon expansion of the expandable means and stent releasingthe stent by sliding axially from over the stent.
 103. The stentdelivery system of claim 102 wherein the stent is generally tubular inshape and the mounting body is generally ring-like in shape.
 104. Thestent delivery system of claim 102 wherein at least two spaced mountingbodies are included.
 105. The stent delivery system of claim 102 whereinat least three spaced mounting bodies are included.
 106. The stentdelivery system of claim 102 wherein at least four spaced mountingbodies are included.
 107. The system according to claim 1 , the cathetercomprising a shaft, the inflatable means comprising a balloon associatedwith a distal portion of the shaft for receiving a stent, and means forinflating the balloon, the securement component including at least onering-like mounting body carried on the shaft inside the balloon wherebythe diameter of the shaft is increased inside the balloon to facilitatemounting of a stent to the catheter over the balloon and furtherincluding, the system further comprising a first and second sleeve inthe distal part of the catheter positioned around the catheter, eachhaving a first end fixed to the catheter and a second end overlyingfirst and second end portions of the stent respectively, the first andsecond sleeves separately fixing the stent before expansion thereof andupon expansion of the expandable means and stent releasing the stent bysliding axially from over the stent.